Viveve Medical Ipo Prospectus

Viveve medical ipo prospectus

 

As filed with the Securities and Exchange Commission on November

21

, 2019

Registration No. 333-233639                 



 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C.

20549


 

AMENDMENT NO. 4

TO

FORM S-1
REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933


 

VIVEVE MEDICAL, INC.
(Exact name of registrant as specified in its charter)


 

Delaware

 

3841

 

04-3153858

(State or other jurisdiction of

incorporation or organization)

 

(Primary Standard Industrial

Classification Code Number)

 

(I.R.S.

Employer
Identification Number)

 

345 Inverness Drive South
Building B, Suite 250
Englewood, CO 80112
Telephone: (720) 696-8100
(Address, including zip code and telephone number, including area code, of registrant’s principal executive offices)


 

Scott Durbin
345 Inverness Drive South
Building B, Suite 250
Englewood, CO 80112
Telephone: (720) 696-8100
(Name, address, including zip code and telephone number, including area code, of agent for service)


 

Copies to:

 

Mitchell S.

Bloom, Esq.

Bradley A. Bugdanowitz, Esq.

Michael D. Maline, Esq.

Goodwin Procter LLP

Three Embarcadero Center, 28th Floor

San Francisco, California 94111

(415) 733-6000

Michael F. Nertney, Esq.

Ellenoff Grossman & Schole LLP

1345 Avenue of the Americas

New York, New York 10105

(212) 370-1300

 


 

Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective date of the registration statement.

 

If any of the securities being registered on this form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, as amended (the “Securities Act”), check the following box.

CON Job: How a Little Known Law Prevents Access to Healthcare

 

If this form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ☐

 

 

If this form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ☐

 

If this form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company.

See the definitions of “large accelerated filer,” “accelerated filer” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Viveve medical ipo prospectus

(Check one):

 

Large accelerated filer  ☐

Accelerated filer  ☒

Non-accelerated filer  ☐

Smaller reporting company  ☒

 

Emerging growth company  ☐

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided to Section 7(a)(2)(B) of the Securities Act.

 

CALCULATION OF REGISTRATION FEE

 

Title of Each Class of Securities to be Registered

 

Proposed

Maximum

Aggregate

Offering

Price(1)

  

Amount of

Registration

Fee(2)

 

Class A Units consisting of:

        

(i) shares of Common Stock, par value $0.0001 per share(3)

 $3,500,000  $454.30 

(ii)  Warrants to purchase Common Stock(3)(4)

        

Class B Units consisting of:

        

(i) shares of Series A Preferred Stock, par value $0.0001 per share(3)

 $8,000,000  $1,038.40 

(ii)   Common Stock issuable on conversion of Series A Preferred Stock(3)(5)

        

(iii)  Warrants to purchase Common Stock(3)(4)

        

Common Stock issuable upon exercise of warrants(3)

 $23,000,000  $2,985.40 

Total

 $34,500,000  $4,478.10(6)  

 


(1)

Estimated solely for the purpose of computing the registration fee pursuant to Rule 457(o) under the Securities Act of 1933, as amended.

Viveve medical ipo prospectus

Also includes the offering price of additional units that the underwriter has the option to purchase.

(2)

Calculated pursuant to Rule 457(o) based on an estimate of the proposed maximum aggregate offering price of all securities being registered.

(3)

Pursuant to Rule 416, the securities being registered hereunder include such indeterminate number of additional securities as may be issued after the date hereof as a result of stock splits, stock dividends or similar transactions.

(4)

No fee pursuant to Rule 457(g) under the Securities Act of 1933, as amended.

(5)

No fee pursuant to Rule 457(i) under the Securities Act of 1933, as amended.

(6)

This full amount was previously paid.

 

 

The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

 

 

The information in this prospectus is not complete and may be changed.

We may not sell these securities until the registration statement relating to these securities filed with the Securities and Exchange Commission is effective.

 

PRELIMINARY PROSPECTUS
(SUBJECT TO COMPLETION)

 

DATED: NOVEMBER 21, 2019

 

 

 

662,252 Class A Units consisting of shares of common stock and warrants to purchase up

to 1,324,504 shares of common stock and

2,649,007 Class B Units consisting of shares of Series A Preferred Stock and warrants to purchase up

to 5,298,014 shares of common stock 

(and 7,947,021 shares of common stock underlying shares of Series A Preferred Stock and such warrants)

 

We are offering Class A Units, with each Class A Unit consisting of one share of common stock, par value $0.0001 per share (the “common stock”), one warrant that expires on the first anniversary of the date of issuance (“Series A warrant”) to purchase one share of our common stock and one warrant that expires on the fifth anniversary of the date of issuance (“Series B warrant”) to purchase one share of our common stock (together with the shares of common stock underlying such warrants, the “Class A Units”) at an assumed public offering price of $3.02 per Class A Unit.

Each Series A warrant included in the Class A Units has an exercise price per share of $       . Each Series B warrant included in the Class A Units has an exercise price per share of $       .

 

We are also offering to those purchasers whose purchase of Class A Units in this offering would result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding common stock following the consummation of this offering, the opportunity to purchase, if they so choose, in lieu of the number of Class A Units that would result in ownership in excess of 4.99% (or, at the election of the purchaser, 9.99%), Class B Units.

Each Class B Unit consists of one share of Series A Preferred Stock, par value $0.0001 per share (the “Series A Preferred Stock”), convertible into one share of common stock, a Series A warrant to purchase one share of common stock and a Series B warrant to purchase one share of common stock (together with the shares of common stock underlying such shares of Series A Preferred Stock and such warrants, the “Class B Units” and, together with the Class A Units, the “units”) at an assumed public offering price of $3.02 per Class B Unit.

Each Series A warrant included in the Class B Units has an exercise price per share of $        . Each Series B warrant included in the Class B Units has an exercise price per share of $        .

 

The Class A Units and Class B Units have no stand-alone rights and will not be certificated or issued as stand-alone securities.

Viveve medical ipo prospectus

The shares of common stock, Series A Preferred Stock, Series A warrants and Series B warrants comprising such units are immediately separable and will be issued separately in this offering. The underwriter has the option to purchase additional shares of common stock, Series A warrants and/or Series B warrants to purchase shares of common stock solely to cover over-allotments, if any, at the price to the public less the underwriting discounts and commissions.

The over-allotment option may be used to purchase shares of common stock, Series A warrants or Series B warrants, or any combination thereof, as determined by the underwriter, but such purchases cannot exceed an aggregate of 15% of the number of shares of common stock (including the number of shares of common stock issuable upon conversion of shares of Series A Preferred Stock) and Series A warrants and Series B warrants sold in the primary offering.

The over-allotment option is exercisable for 45 days from the date of this prospectus.

 

Our common stock is listed on the NASDAQ Capital Market under the symbol “VIVE.” On November 18, 2019, the last reported sale price of our common stock on the NASDAQ Capital Market was $3.02.

The recent market price used throughout this prospectus may not be indicative of the final offering price. The final public offering price will be determined through negotiation between us and the underwriter based upon a number of factors, including our history and our prospects, the industry in which we operate, our past and a present operating results, the previous experience of our executive officers and the general condition of the securities markets at the time of this offering.

 

Investing in our securities involves a high degree of risk.

You should review carefully the risks and uncertainties described under the heading “Risk Factors” beginning on page 10 of this prospectus, and under similar headings in any amendments or supplements to this prospectus.

 

 

  

Per Class

A Unit

  

Per Class

B Unit

  

Total

 

Public offering price(1)

 $   $   $  

Underwriting discounts and commissions(2)(3)

 $   $   $  

Proceeds, before expenses, to Viveve Medical, Inc.

 $   $   $  

 

(1)

The public offering price and underwriting discount corresponds to (x) in respect of the Class A Units (i) a public offering price per share of common stock of $      , (ii) a public offering price per Series A warrant of $                , and (iii) a public offering price per Series B warrant of $        and (y) in respect of the Class B Units (i) a public offering price per share of Series A Preferred Stock of $               , (ii) a public offering price per Series A warrant of $               , and (iii) a public offering price per Series B warrant of $        .

 

(2)

We have also agreed to reimburse Ladenburg Thalmann for certain expenses.

See “Underwriting” for additional information.

 

(3)

We have granted a 45-day day option to the underwriter to purchase additional shares of common stock, Series A warrants to purchase shares of common stock and/or Series B warrants to purchase shares of common stock (up to 15% of the number of shares of common stock (including the number of shares of common stock issuable upon conversion of shares of Series A Preferred Stock), Series A warrants and Series B warrants sold in the primary offering) solely to cover over-allotments, if any.

 

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of this prospectus.

Any representation to the contrary is a criminal offense.

 

The underwriter expects to deliver the securities to purchasers in the offering on or about           , 2019.

 

Ladenburg Thalmann

 

The date of this prospectus is                     , 2019

 

 

TABLE OF CONTENTS

 

PROSPECTUS SUMMARY

1

THE OFFERING

8

RISK FACTORS

11

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

38

USE OF PROCEEDS

39

MARKET FOR COMMON STOCK

40

DIVIDEND POLICY

41

DILUTION

42

CAPITALIZATION

43

DESCRIPTION OF SECURITIES

44

UNDERWRITING

53

INCORPORATION OF CERTAIN INFORMATION BY REFERENCE

57

WHERE YOU CAN FIND MORE INFORMATION

58

LEGAL MATTERS

59

EXPERTS

59

 

You should rely only on the information contained in this prospectus or in any related free writing prospectus filed by us with the Securities and Exchange Commission, or the SEC.

We have not, and the underwriters and their affiliates have not, authorized anyone to provide you with any information or to make any representation not contained in this prospectus. We do not, and the underwriters and their affiliates do not, take any responsibility for, and can provide no assurance as to the reliability of, any information that others may provide to you. This prospectus is not an offer to sell or an offer to buy securities in any jurisdiction where offers and sales are not permitted.

The information in this prospectus is accurate only as of its date, regardless of the time of delivery of this prospectus or any sale of securities.

You should also read and consider the information in the documents to which we have referred you under the caption “Where You Can Find More Information” in the prospectus.

 

Neither we nor the underwriters have done anything that would permit a public offering of the securities or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the United States.

VIVEVE MEDICAL, INC – S-1 IPO Investment Prospectus

Persons outside the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of the securities and the distribution of this prospectus outside of the United States.

 

We urge you to read carefully this prospectus, as supplemented and amended, before deciding whether to invest in any of the common stock being offered.

 

Unless the context indicates otherwise, as used in this prospectus, the terms “Viveve,” “the Company,” “we,” “us,” and “our” refer to Viveve Medical, Inc.

and its wholly-owned subsidiary, Viveve, Inc.

 

We use various trademarks and trade names in our business, including without limitation our corporate name and logo.

All other trademarks or trade names referred to in this prospectus are the property of their respective owners. Solely for convenience, the trademarks and trade names in this prospectus may be referred to without the ® and ™ symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto.

 

 

PROSPECTUS SUMMARY

 

The following summary highlights information contained elsewhere in this prospectus.

This summary may not contain all of the information that may be important to you.

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Because it is only a summary, it does not contain all of the information that you should consider before investing in shares of our securities and it is qualified in its entirety by, and should be read in conjunction with, the more detailed information appearing elsewhere in this prospectus and the documents incorporated by reference, including the section titled “Risk Factors” and our historical consolidated financial statements and related notes included elsewhere in this prospectus.

 

Overview

 

Viveve designs, develops, manufactures and markets a platform medical technology, which we refer to as Cryogen-cooled Monopolar RadioFrequency, or CMRF.

Our proprietary CMRF technology is delivered through a radiofrequency generator, handpiece and treatment tip, that collectively, we refer to as the Viveve® System.

Form S-1/A Viveve Medical, Inc.

The Viveve System is currently being marketed around the world (outside of the United States) for the non-invasive treatment of vaginal introital laxity, sexual function, vaginal rejuvenation, and stress urinary incontinence depending on the relevant country-specific clearance or approval, that we refer to as the Viveve Treatment.

 

           

 

 

At this time, the Viveve System is indicated for use and being marketed for use in general surgical procedures for electrocoagulation and hemostasis in the United States.

The device has not been cleared or approved for use for the treatment of vaginal laxity, to improve sexual function, for vaginal rejuvenation, or for stress urinary incontinence in the United States.

Accordingly, the Company is prohibited under current U.S. regulations from promoting it to physicians or consumers for these unapproved uses.

 

We believe the Viveve System provides a number of benefits for physicians and patients, including:

 

 

a non-invasive, non-ablative treatment with a demonstrated history of safety;

 

 

it typically requires only a single treatment;

 

 

compelling physician economics; and

 

 

ease of use.

 

 

Currently, the Viveve System is cleared for marketing in 57 countries throughout the world, under the following indications for use: 

 

 Indication of Use

No.

of Countries

General surgical procedures for electrocoagulation and hemostasis

 4 (including the U.S.)

General surgical procedures for electrocoagulation and hemostasis of vaginal tissue and for the treatment of vaginal laxity

32

For treatment of vaginal laxity

4

For treatment of the vaginal introitus, after vaginal childbirth, to improve sexual function

14

General surgical procedures for electrocoagulation and hemostasis and for the treatment of vaginal laxity

1

For vaginal rejuvenation

1

For treatment of vaginal laxity, urinary incontinence and sexual function

1

 

 

The Viveve System is comprised of three main components: a radiofrequency generator housed in a table-top console; a reusable handpiece; and a single-use treatment tip.

Single-use accessories (e.g. RF return pad, coupling fluid), a cryogen canister that can be used for approximately two to five procedures (depending on the procedure type and pulses used), and a foot pedal are also included with the System.

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Practitioners attach the single-use treatment tip to the handpiece. The generator then authenticates the treatment tip and programs the system for the desired treatment without further intervention. The treatment is performed in a physician’s office and does not require the use of anesthesia.

The tissue remodeling effect resulting from the Viveve treatment has been demonstrated by our pre-clinical and clinical research.

 

     

 

 

Our goal is to become the leading provider of non-invasive solutions to treat certain women’s intimate health conditions by:

 

 

Broadening the conditions we treat through robust clinical trials and regulatory label expansion.

In addition to pursuing clearance/approval in the U.S. for the improvement of symptoms of female sexual dysfunction associated with vaginal laxity, we intend to conduct several clinical trials, and if successful, submit for regulatory clearance/approval in the U.S.

and abroad for stress urinary incontinence and potentially vulvovaginal atrophy.

 

 

Increasing the Number of Installed Base of Viveve Systems.

In our existing markets, we plan to (i) expand the number of Viveve Systems by leveraging our current and future clinical study results and through innovative marketing programs directed at both physicians and patients, where permissible by law, and (ii) expand our efforts and obtain regulatory approvals in additional markets, although there are no assurances that we will ever receive such approvals.

 

 

 

Driving Increased Treatment Tip Usage.

We work collaboratively with our physician customer base to increase treatment tip usage by enhancing customer awareness and facilitating the marketing efforts of our physician customers to their patients, where permitted by law.

We intend to launch innovative marketing programs with physician customers, where permitted by law, to develop high volume Viveve practices.

 

 

Broadening Our Customer Base. While our initial focus is on marketing our procedure to the aesthetics and OB/GYN specialty, we intend to selectively expand our sales efforts into other physician specialties, as permitted by the law, such as urology, urogynecology, general surgery and family practice.

Additionally, we intend to pursue leases and sales from physician-directed medi-spas with track records of safe and successful treatments as permitted by the law.

 

 

Developing New Treatment Tips and System Enhancements.

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We intend to continue to expand our line of treatment tips that, in the future, may allow for shorter procedure times to benefit both physicians and patients. We also plan to pursue potential system modifications and next generation enhancements that will further increase the ease-of-use of the Viveve System.

 

 

Investing in Intellectual Property and Patent Protection.

We will continue to defend and invest in expanding our intellectual property portfolio, and we intend to file for additional patents and trademarks, as necessary, to strengthen our intellectual property rights.

 

As of September 30, 2019, we have a global installed base of 805 Viveve Systems and we have sold approximately 39,150 single-use treatment tips worldwide.

 

Recent Developments

 

CRG Debt Conversion and Lock-Up

 

On November 12, 2019, we entered into an agreement, which was subsequently amended by Amendment No.

1 on November 20, 2019, with affiliates of CRG LP (“CRG”) pursuant to which CRG agreed to convert approximately $29.0 million of the outstanding principal amount under our Term Loan Agreement with CRG (the “2017 Loan Agreement”) (plus accrued interest, prepayment premium and back-end fee relating thereto, for an aggregate amount of converted obligations of $31.3 million) into a newly authorized series of non-voting convertible preferred stock (the “Series B Preferred Stock”), convertible into our common stock at a price per share equal to the price of the shares included in the Class A Units offered hereby (the “Series B Conversion Price”).

Such conversion of debt (the “CRG Conversion”) is contingent upon the closing of this offering.

 

CRG will also receive warrants for 15% of our common stock on a fully diluted basis after taking into account the CRG Conversion (the “CRG Warrants”), and this offering (including, the underwriter’s exercise of its over-allotment option, if any).

The CRG Warrants will have a term of five years and a strike price equal to 120% of the Series B Conversion Price.

 

Under the terms of such agreement, the holders of Series B Preferred Stock will be entitled to receive compounding dividends at a rate of 12.5% per annum payable quarterly at the Company’s option, in-kind in additional shares of Series B Preferred Stock or in cash.

The shares of Series B Preferred Stock will have no voting rights and will rank senior to all other classes and series of our equity in terms of repayment and certain other rights.

ex_163821.htm

The holders of the Series B Preferred Stock and the CRG Warrants will have customary resale and piggy back registration rights with respect to common stock issuable upon conversion of the Series B Preferred Stock or the exercise of the CRG Warrants (the “Conversion Shares”). Under the terms of the agreement, as amended, CRG will not convert the Series B Preferred Stock or exercise the CRG Warrants until our stockholders act to authorize additional number of shares of common stock sufficient to cover the Conversion Shares.

 

In addition, the issuance of Conversion Shares will be subject to stockholder approval if and to the extent they exceed 19.99% of our pre-transaction outstanding common stock.

The summary of terms of the Series B Preferred Stock and CRG Warrants above is qualified in its entirety by the Certificate of Designation of Series B Preferred Stock (the “Series B Certificate of Designation”), the related form of warrant, registration rights agreement and the Series B Preferred Stock and Warrant Purchase Agreement, as amended by Amendment No.

1. Please refer to the Series B Certificate of Designation, the related form of warrant, the registration rights agreement, the Series B Preferred Stock and Warrant Purchase Agreement and Amendment No. 1 to the same for more information on the preferences, rights and limitations of the Series B Preferred Stock and CRG Warrants, which documents are filed as exhibits to the registration statement of which this prospectus forms a part.

 

In connection with the CRG Conversion, certain terms in the 2017 Loan Agreement are also amended.

The cash payments for interest due on the remaining amount of indebtedness under the 2017 Loan Agreement is deferred, and we will instead pay the 12.5% interest in the form of payment in kind (“PIK”) loans. Further, under the agreement, the Company is no longer obligated to meet certain minimum revenue thresholds in order to comply with the terms of the 2017 Loan Agreement.

 

The Series B Preferred Stock, CRG Warrants and any of our common stock issued upon conversion of the Series B Preferred Stock or the exercise of the CRG Warrants will be subject to a lock-up period of one year following the date of the underwriting agreement for this offering.

This means that, during the applicable lock-up period, CRG may not offer for sale, contract to sell, distribute, grant any option, right or warrant to purchase, pledge, hypothecate or otherwise dispose of, directly or indirectly, the shares of Series B Preferred Stock or any securities acquired under the agreement convertible into, or exercisable or exchangeable for, shares of our common stock.

CRG has also agreed, in an agreement with the underwriters, to similar lock-up restrictions on the resale or transfer of such securities for one year following the effectiveness of the underwriting agreement.

Viveve medical ipo prospectus

The representative may, in its sole discretion and without notice, waive the terms of any of these lock-up agreements.

 

 

Reverse Stock Split

 

On September 18, 2019, we filed a Certificate of Amendment to our Restated Certificate of Incorporation with the Secretary of State of the State of Delaware to effect a 1-for-100 reverse stock split of our issued and outstanding common stock.

The reverse stock split became effective at 5:00 p.m. Eastern Time on September 18, 2019 and our common stock began trading on a split-adjusted basis on The Nasdaq Capital Market on September 19, 2019. All issued and outstanding common stock, options and warrants exercisable for common stock, restricted stock units, preferred stock conversions to common stock and per share amounts contained in our condensed consolidated financial statements have been retrospectively adjusted.

 

Nasdaq Delisting Notices

 

On May 13, 2019 and May 21, 2019, the Company received written notices from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) notifying it that the Company was not in compliance with the minimum bid price requirements as well as the market value of listed securities requirements.

Both notification letters state that the Company has 180 calendar days, or until November 11, 2019 and November 18, 2019, respectively, to regain compliance.

 

Following our reverse stock split described above, on October 3, 2019, the Company was notified by Nasdaq that as of October 2, 2019, it had maintained a closing bid above $1.00 for a period of 10 consecutive trading days and therefore had regained compliance with the minimum bid price requirement.

There can be no assurance that the Company will continue to be in compliance with the minimum bid price requirement or comply with Nasdaq’s other continued listing standards in the future.

 

On November 19, 2019, we received a notice from Nasdaq that our securities would be subject to delisting from The Nasdaq Capital Market for failure to regain compliance with the market value of listed securities requirement under Nasdaq Listing Rule 5550(b)(2), unless we timely request a hearing before a Nasdaq Hearings Panel (the "Panel").

We intend to timely request a hearing before the Panel, which will stay any delisting action by Nasdaq. At the hearing, we intend to present our plan to demonstrate compliance with the market value of listed securities requirement or an alternative stockholders’ equity requirement under Nasdaq Listing Rule 5550(b)(1) or net income requirement under Nasdaq Listing Rule 5550(b)(3).

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There can be no assurance that the Panel will grant our request for continued listing pursuant to an exception to the market value of listed securities requirement or that we will be able to regain compliance with the market value of listed securities requirement or any alternative requirement under Nasdaq Listing Rules 5550(b)(1) or 5550(b)(3).

 

In the event that part of our outstanding indebtedness under the 2017 Loan Agreement is converted to Series B Preferred Stock in connection with the CRG Conversion, we expect to gain compliance with the stockholders’ equity requirement under Nasdaq Listing Rule 5550(b)(1).

 

CE Mark Clearance for Next Generation 2.0 Platform in Europe

 

In April 2019, the Company received CE Mark clearance for its next generation Viveve 2.0 CMRF system and tips in European Union and European Economic Area countries.

As part of our ongoing regulatory strategy to expand the commercial launch of our Viveve 2.0 CMRF system globally, the Company’s next generation system and its consumable treatment tips are now available in over 30 countries in Europe. The Company’s Viveve 2.0 CMRF system significantly reduced manufacturing costs for both the next generation system and for the consumable tips since becoming available in the U.S. and it should have a positive impact on our overall gross margins going forward.

 

 

Enrollment Completed in VIVEVE II Clinical Study

 

In March 2019, enrollment was completed for the VIVEVE II (Viveve treatment of the Vaginal Introitus to EValuate Effectiveness) clinical study following Investigational Device Exemption, or IDE, approval by the FDA.

This is a prospective, randomized, double-blind, sham controlled study to evaluate the efficacy and safety of the Viveve System to improve symptoms of female sexual disfunction, associated with vaginal laxity. Nineteen (19) active clinical sites in the United States enrolled 250 female patients who were pre-menopausal, 18 years of age or older who experienced at least one full term vaginal delivery at least twelve months prior to enrollment date, randomized in a 2:1 ratio to either an active treatment group or sham-control group.

Patients will be followed for twelve months post-treatment to assess the primary effectiveness and safety endpoints of the study with data being collected at one, three, six, nine and twelve months.

Patients randomized to the sham arm will be offered the opportunity to receive a Viveve treatment once they have completed the twelve-month evaluation following the sham intervention.

 

The primary efficacy endpoint of the study is the mean change from baseline in the Female Sexual Function Index (FSFI) total score at twelve months post treatment.

Form S-1 Viveve Medical, Inc.

Secondary endpoints include evaluation of the mean change from baseline of the total FSFI score at six months, as well as evaluation of the mean change from baseline of the six different domains within the FSFI at six and twelve months. At months six and twelve, in addition to the FSFI, subjects will be asked to complete the Patient’s Global Impression of Improvement (PGI-I).

Subjects will also be assessed for adverse events throughout the study.

Viveve medical ipo prospectus

The Company intends to report final twelve-month clinical data from the study in the second quarter of 2020.

 

Clinical Results Reported from LIBERATE-International SUI Trial